Dietary supplement industry gets its due with GMP requirements
WHAT IT MEANS AND WHY IT'S IMPORTANT The dietary supplement industry is free at last from any major news organization making any kind of assertion that the industry is “unregulated.”
(THE NEWS: CRN: Dietary supplement manufacturers must be GMP-compliant. For the full story, click here)
To recap, all of the dietary supplement industry must conform to best manufacturing practice standards that were designed specifically for this industry, and consequently are more strict, per se, than the food good manufacturing practices that supplement manufacturers had to live up to prior. Now all that’s left is for the FDA actually to begin touring supplement manufacturing plants and begin enforcing the new GMPs across the industry.
And make no mistake about it, the Council for Responsible Nutrition’s Steve Mister was sincere when he said the supplement industry welcomes the opportunity to live up to these requirements. The CRN — as well as other supplement associations — have been calling for the implementation of supplement-specific GMPs for about the last 15 years, or ever since the Dietary Supplement Health and Education Act of 1994 was passed. Under a similar vein, they have advocated the implementation of serious adverse event reporting requirements and have partnered with the National Advertising Division on a voluntary program to help either substantiate or disavow any questionable supplement claims.
And the reason is simple. This industry has worked long and hard to distance itself from those entities masquerading as supplement companies with their long line of adulterated drug products — steroids, for example, or the products advertised in online ads for “natural” erectile dysfunction, or weight-loss supplements that actually contain pharmaceutical medicines.
Including these “companies” under the umbrella of the supplement industry is kind of like suggesting corner drug dealers are more or less “pharmaceutical redistributors” that fall under the umbrella of healthcare practitioners. The end game, after all, is consumer confidence. And that confidence is best earned in the clear light of day.
Moreover, what it does NOT mean is that this industry will be free from criticism. And that’s absolutely okay, too. Because chances are that criticism now will circle around sound science (e.g., peer-reviewed clinical studies) rather than what does or does not constitute a regulated industry.